Vinblastine and Methotrexate in Treating Children With Desmoid Tumors

July 24, 2014 updated by: Children's Oncology Group

Vinblastine and Methotrexate in Children With Desmoid Tumor (Aggressive Fibromatosis) Which is Recurrent or Not Amenable to Surgical Resection or Irradiation - A Pediatric Oncology Group Phase II Study

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy with vinblastine and methotrexate in treating children who have desmoid tumors that are recurrent or untreatable with surgery or radiation therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Estimate the efficacy and toxicity of vinblastine and methotrexate for newly diagnosed or recurrent desmoid tumors in children who are not good candidates for treatment with surgery or radiation therapy.

OUTLINE: Patients receive vinblastine and methotrexate IV weekly for 26 weeks, then every 2 weeks for an additional 26 weeks. Treatment continues for a maximum of 1 year in the absence of unacceptable toxicity or disease progression. Patients with a complete response receive an additional 8 doses of chemotherapy. Patients are followed every 6 months for 4 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 13-25 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Western Australia
      • Perth, Western Australia, Australia, 6001
        • Princess Margaret Hospital for Children
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3V4
        • British Columbia Children's Hospital
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3J 3G9
        • IWK Grace Health Centre
  • United States
    • California
      • Long Beach, California, United States, 90806
        • Long Beach Memorial Medical Center
      • Los Angeles, California, United States, 90095-1781
        • Jonsson Comprehensive Cancer Center, UCLA
      • Los Angeles, California, United States, 90027-0700
        • Children's Hospital Los Angeles
      • Orange, California, United States, 92668
        • Children's Hospital of Orange County
      • San Francisco, California, United States, 94115-0128
        • UCSF Cancer Center and Cancer Research Institute
      • Travis Air Force Base, California, United States, 94535
        • David Grant Medical Center
    • Colorado
      • Denver, Colorado, United States, 80218
        • Children's Hospital of Denver
    • District of Columbia
      • Washington, District of Columbia, United States, 20010-2970
        • Children's National Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Cancer Research Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202-5265
        • Indiana University Cancer Center
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0752
        • University of Michigan Comprehensive Cancer Center
      • Kalamazoo, Michigan, United States, 49007-3731
        • CCOP - Kalamazoo
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Cancer Center
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Cancer Center
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Children's Mercy Hospital
    • Nebraska
      • Omaha, Nebraska, United States, 68198-3330
        • University of Nebraska Medical Center
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Cancer Institute of New Jersey
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, United States, 10016
        • NYU School of Medicine's Kaplan Comprehensive Cancer Center
      • New York, New York, United States, 10032
        • Herbert Irving Comprehensive Cancer Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7295
        • Lineberger Comprehensive Cancer Center, UNC
    • North Dakota
      • Fargo, North Dakota, United States, 58102
        • Veterans Affairs Medical Center - Fargo
      • Fargo, North Dakota, United States, 58122
        • CCOP - Merit Care Hospital
    • Ohio
      • Cincinnati, Ohio, United States, 45229-3039
        • Children's Hospital Medical Center - Cincinnati
      • Cleveland, Ohio, United States, 44106-5065
        • Ireland Cancer Center
      • Columbus, Ohio, United States, 43205-2696
        • Children's Hospital of Columbus
    • Oregon
      • Portland, Oregon, United States, 97201-3098
        • Doernbecher Children's Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia
      • Pittsburgh, Pennsylvania, United States, 15213
        • Children's Hospital of Pittsburgh
    • Tennessee
      • Nashville, Tennessee, United States, 37232-6838
        • Vanderbilt Cancer Center
    • Texas
      • Houston, Texas, United States, 77030-4009
        • University of Texas - MD Anderson Cancer Center
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Huntsman Cancer Institute
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Research Center
      • Seattle, Washington, United States, 98105
        • Children's Hospital and Regional Medical Center - Seattle
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS: Histologically proven, untreated, primary desmoid tumor (aggressive fibromatosis) for which surgery and/or radiation therapy is not thought to be feasible (prior attempted surgical resection allowed if gross residual disease remains) No other fibroblastic lesions or other fibromatoses allowed Recurrent desmoid tumor not previously treated with vinca alkaloids or methotrexate and no chemotherapy since recurrence Measurable disease by MRI

PATIENT CHARACTERISTICS: Age: Under 19 at time of diagnosis Performance status: Not specified Life expectancy: Not specified Hematopoietic: Hemoglobin normal for age WBC normal for age Platelet count normal for age Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) for age SGOT less than 1.5 times ULN for age Renal: Creatinine less than 1.5 times ULN for age

PRIOR CONCURRENT THERAPY: See Disease Characteristics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chemotherapy Treatment
Patients receive vinblastine sulfate (5 mg/m2) IV and methotrexate (30 mg/m2) IV weekly for 26 weeks, then every 2 weeks for an additional 26 weeks. Treatment continues for a maximum of 1 year in the absence of unacceptable toxicity or disease progression. Patients with a complete response receive an additional 8 doses of chemotherapy. Patients are followed every 6 months for 4 years and then annually thereafter.
Drug: methotrexate
Other Names:
  • amethopterin
  • MTX
  • NSC #000740
Drug: vinblastine sulfate
Other Names:
  • Velban
  • VBL
  • vincaleukoblastine
  • NSC #49842

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Event Free Survival
To estimate the efficacy and toxicity of vinblastine and methotrexate for desmoid tumor in children with newly diagnosed or recurrent desmoid tumor who are not good candidates for treatment with surgery or radiation therapy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Oncology Group

Collaborators

National Cancer Institute (NCI)
Children's Cancer Group

Investigators

  • Study Chair: Steve Skapek, MD, St. Jude Children's Research Hospital
  • Study Chair: Bruce Himelstein, MD, Children's Hospital of Philadelphia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 1997

Primary Completion (Actual)

July 1, 2003

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

August 3, 2000

First Submitted That Met QC Criteria

April 29, 2004

First Posted (Estimate)

April 30, 2004

Study Record Updates

Last Update Posted (Estimate)

July 25, 2014

Last Update Submitted That Met QC Criteria

July 24, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9650
  • POG-9650 (Other Identifier: Pediatric Oncology Group)
  • CCG-P9650 (Other Identifier: Children's Cancer Group)
  • CDR0000065601 (Other Identifier: Clinical Trials.gov)
  • COG-P9650 (Other Identifier: Children's Oncology Group)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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